Talent.com
Scientist 2 - Post-Market Investigations
Scientist 2 - Post-Market InvestigationsHologic • San Diego, CA, United States, CA, United States
Scientist 2 - Post-Market Investigations

Scientist 2 - Post-Market Investigations

Hologic • San Diego, CA, United States, CA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

We are hiring a highly motivated Scientist 2 in our Diagnostic division, Quality Technical Investigations (QTI) team. In this role and under QA function, you will coordinate and lead high complexity investigations related to customer complaints for assay reagents in Hologic's quality management system and moderate / high complexity projects in support of compliance and overall Hologic continuous improvement efforts. The incumbent will provide Technical Subject Matter Expertise (SME) to all levels of staff including QTI team as well as advising leadership as required. You may be responsible for communicating complex information to the key stake holders for effective decision making. When needed you may be responsible for performing laboratory hands on work to support QTI team’s projects, tasks etc.

This is a fully onsite role in San Diego, CA.

Essential Duties and Responsibilities :

Key Responsibilities :

  • Leads and completes field support activities including addressing inquiries and troubleshooting tasks in a timely manner.
  • Leads root cause analysis of high complexity investigations including critical technical review, planning, execution, data analysis, obtaining information, materials and other required support from cross functional teams.
  • May execute investigations at customer sites for thorough understanding of the issues relevant to complex and high-risk products based on business needs.
  • Authors and / or reviews HHE, PI, ECO / DR, Risk Analysis and other high complexity quality documents as needed.
  • Identifies risks, develops mitigation strategies, and ensures project deliverables are achieved.
  • Creates and verifies data sets and performs comprehensive analysis using appropriate statistical analysis tools to support customer complaint investigations and process improvements with varying levels of complexity.
  • Authors high complexity technical protocols, reports, quality documents, and complaint investigation reports with high quality and relatively less turnaround time.
  • Provides technical support during internal and / or third-party audits as needed.

Leadership and Collaboration :

  • Leads project(s) to support process improvements and compliance.
  • Identifies specific action steps, accountabilities and timelines for completion of project(s) and investigations.
  • Manages priorities and secures support from peers, cross functional SME and leadership team.
  • Develops short or long-term plans with appropriate contingencies to ensure objectives are met with high probability of success.
  • Leads as an SME in efficient trouble shooting and root cause identification based on evidence to address escalated complaints while synthesizing novel ideas.
  • Demonstrates leadership in decision making while understanding the implications of decisions for the business.
  • Manages junior level team employees.
  • Collaborates with cross functional SMEs for successful completion of project(s), investigations etc, lead and execute proactive quality initiatives.
  • Collaborates and communicates effectively with junior level employees, peers, cross-functional teams across the organization as needed.
  • Represents QTI on a Core Team for a moderate to high complex project.
  • Prepares and Present results, issues, progress and other critical information to different audiences including key stakeholders and the leadership team as needed.
  • Training & Mentorship :

  • Provide technical guidance and mentorship to junior scientists and quality engineers.
  • Share best practices for root cause analysis and technical problem-solving.
  • Continuous Improvement :

  • Shows initiative and gains in depth knowledge of existing and new Hologic products, platforms, assay design and chemistries and applies the knowledge for investigations and troubleshooting purposes as needed.
  • Continues to gain in depth knowledge of US and OUS quality regulations for IVD products.
  • Identifies and implements process improvements to reduce customer complaints and enhance product quality. Uses data driven metrics to track and assess the effectiveness of improvements.
  • Demonstrates resilience and composure in difficult circumstances.
  • Additional Responsibilities :

  • Leads additional projects / processes in support of compliance and quality requirements.
  • Serves as a mentor on Quality principles to employees across all levels.
  • Maintains detailed knowledge of relevant quality system regulations (e.g., 21 CFR Parts 806 and 820, ISO 13485, and ISO 14971).
  • Required Qualifications and Experience :

  • Bachelor’s, Master’s or Ph.D. in Chemistry, Biochemistry, Molecular Biology, Biomedical Engineering, or related scientific discipline.
  • Experience :

  • 2 - 5 years of industrial experience post-baccalaureate
  • 1 - 3 years of industrial experience post M.S
  • 1 year of industrial experience post PhD
  • Experience in the Molecular Diagnostics industry preferably with experience in identifying technical solutions to customer-facing problems associated with IVD products is desirable.
  • Demonstrated expertise in technical investigation, root cause analysis, and scientific problem-solving.
  • Experience with complaint investigation, CAPA, and quality systems (FDA, ISO 13485, EU MDR).
  • Understanding of 21 CFR, ISO 13485, ISO 14971 and other regulations relevant to Molecular Diagnostic Industry is desired.
  • Experience with manufacturing and design of IVD products is desired.
  • Technical Skills :

  • Technical expertise with a strong emphasis on leading projects and investigations is preferred.
  • Proficient in laboratory techniques relevant to Hologic’s products (e.g., PCR, immunoassay, analytical chemistry).
  • Strong skills in data analysis, statistics, and scientific documentation.
  • Understanding of quality assurance and quality engineering principles such as risk management, investigations and statistical methods is preferable.
  • Soft Skills :

  • Strong analytical, critical thinking, and organizational abilities.
  • Excellent written and verbal communication skills.
  • Ability to work both independently and collaboratively in cross-functional teams.
  • Experience with successful preparation and presentation of high complexity documentation and information across all levels of audience is desired
  • So why join Hologic?

    We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role.

    From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more.

    The annualized base salary range for this role is $95,800 - $149,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

    Agency And Third Party Recruiter Notice

    Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

    Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

    #LI-RF1 #onsite

    serp_jobs.job_alerts.create_a_job

    Scientist • San Diego, CA, United States, CA, United States

    Job_description.internal_linking.related_jobs
    Customs and Border Protection Officer - Experienced - Location incentives

    Customs and Border Protection Officer - Experienced - Location incentives

    U.S. Customs and Border Protection • Tecate, CA
    serp_jobs.job_card.full_time
    Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of high...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Exploratory Biomarker Data Scientist

    Exploratory Biomarker Data Scientist

    Novartis Group Companies • San Diego, CA, United States
    serp_jobs.job_card.full_time
    Our innovative neuroscience disease area is looking for a data scientist or computational biologist, based at our San Diego site, with expertise in biomarker data analysis.This key role will join a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Data Science Innovation Postdoctoral Fellow, Diseases of Aging and Regenerative Medicine

    Data Science Innovation Postdoctoral Fellow, Diseases of Aging and Regenerative Medicine

    Novartis Group Companies • La Jolla, CA, United States
    serp_jobs.job_card.full_time
    We are thrilled to seek applications for our Data Science Innovation Fellowship track of the Novartis Postdoctoral Fellowship Program. This applied research program is designed to change the way we ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Customs and Border Protection Officer - Experienced

    Customs and Border Protection Officer - Experienced

    U.S. Customs and Border Protection • Tecate, CA, United States
    serp_jobs.job_card.full_time
    Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of high...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Research Scientist

    Research Scientist

    Novartis Group Companies • San Diego, CA, United States
    serp_jobs.job_card.full_time
    The Neuroscience Disease Area at Novartis is looking for a Research Scientist specializing in histology to perform tissue-based analysis in support of discovery and validation of disease relevant t...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Scientist

    Scientist

    QuidelOrtho • San Diego, CA, United States
    serp_jobs.job_card.full_time
    QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Applied Scientist

    Senior Applied Scientist

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Applied Scientist to develop models for credit risk and fraud functions.Key Responsibilities Collaborate with Risk, Product, and Engineering teams to create and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Customs and Border Protection Officer - Entry Level

    Customs and Border Protection Officer - Entry Level

    U.S. Customs and Border Protection • Alpine, CA, United States
    serp_jobs.job_card.full_time
    Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of high...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Security Researcher

    Principal Security Researcher

    VirtualVocations • Chula Vista, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Security Researcher.Key Responsibilities Perform vulnerability research and reverse engineering for customer tasks Conduct static and dynamic analysis using ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinical Psychologist (PsyD & PhD) - Hybrid Role - Santa Ysabel, CA

    Clinical Psychologist (PsyD & PhD) - Hybrid Role - Santa Ysabel, CA

    LifeStance Health • Santa Ysabel, CA, US
    serp_jobs.job_card.full_time
    We are actively looking to hire talented Psychologists in the San Marcos area, who are passionate about patient care and committed to clinical excellence. Competitive Compensation : $140,000 - $152,0...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Scientist, Applied Genomics

    Principal Scientist, Applied Genomics

    Novartis Group Companies • La Jolla, CA, United States
    serp_jobs.job_card.full_time
    The Applied Genomics group at Novartis, San Diego is actively seeking a highly motivated associate with exceptional cellular / molecular biology and genomic screening experience to support new and on...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Customs and Border Protection Officer - Entry Level - Location incentives

    Customs and Border Protection Officer - Entry Level - Location incentives

    U.S. Customs and Border Protection • Tecate, CA
    serp_jobs.job_card.full_time
    Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of high...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Health Sciences Scientist

    Health Sciences Scientist

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Health Sciences Scientist (PRN) specializing in Nephrology & Hypertension.Key Responsibilities : Conduct independent and collaborative research in various scientific dom...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Postdoctoral Scientist RWE

    Postdoctoral Scientist RWE

    VirtualVocations • El Cajon, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Postdoctoral Scientist in Real World Evidence (RWE).Key Responsibilities Analyze observational databases and historical trial data to generate real-world insights for r...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Space Observations Scientist

    Space Observations Scientist

    VirtualVocations • Chula Vista, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Space Observations Scientist and Organizational Liaison.Key Responsibilities Support the ingestion, monitoring, and quality control of observational data relevant to th...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Principal Scientist I / II, Viral Vector Engineering

    Principal Scientist I / II, Viral Vector Engineering

    Novartis Group Companies • San Diego, CA, United States
    serp_jobs.job_card.full_time
    Position is onsite in San Diego, CA.Internal Title : Principal Scientist I / II.The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capab...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Clinical Psychologist (PsyD & PhD) - Hybrid Role - Dulzura, CA

    Clinical Psychologist (PsyD & PhD) - Hybrid Role - Dulzura, CA

    LifeStance Health • Dulzura, CA, US
    serp_jobs.job_card.full_time
    We are actively looking to hire talented Psychologists in the La Mesa area, who are passionate about patient care and committed to clinical excellence. Competitive Compensation : $140,000 - $152,000....serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Border Patrol Agent - Entry Level - Up to 30k Sign On Bonus

    Border Patrol Agent - Entry Level - Up to 30k Sign On Bonus

    U.S. Customs and Border Protection • Descanso, CA, United States
    serp_jobs.job_card.full_time
    Border Patrol Agent (BPA) GL-5 / 7 grade levels.IMPORTANT NOTICE : Duty assignments available at the time of offer may include the Southwest Border, including prioritized locations.Border Patrol deter...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted